Premature Birth of NewbornSChiROPNCT06729333
A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China
An observational study of Premature Birth of Newborn and Retinopathy of Prematurity (ROP), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Birth of Newborn, Retinopathy of Prematurity (ROP), Low Birthweight Infant
- How many people
- 4,841 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to 17 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tertiary hospital
Who may be able to join
- From December 2024 to May 2025, preterm infants (gestational age <37 weeks) or low birth weight infants (birth weight <2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.
Who cannot join
- Death before the first screening;
- Death or loss to follow-up before complete retinal vascularization;
- Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;
- Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;
- Poor systemic condition preventing fundus examination;
- History of ocular trauma or surgery (excluding treatments for ROP);
- Poor-quality fundus images;
- Other conditions deemed exclusionary by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
About this study
The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.
- Keywords
- retinopathy of prematurity, incidence rate, screening
- Medical subject headings
- Premature Birth, Retinopathy of Prematurity
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of ROP
Measured: 6 months after the first screening
Gestational age at which treatment-requiring ROP develops
Measured: 6 months after the first screening
Birthweight at which treatment-requiring ROP develops
Measured: 6 months after the first screening
Secondary outcomes (5)
Gestational age of infants developing any ROP lesion
Measured: 6 months after the first screening
Birthweight of infants developing any ROP lesion
Measured: 6 months after the first screening
Postmenstrual age (PMA) at which ROP lesions occur
Measured: 6 months after the first screening
PMA at which treatment-requiring ROP occurs
Measured: 6 months after the first screening
Screening and treatment costs
Measured: 6 months after the first screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start3 Dec 2024
- Primary completion17 May 2026
- Study completion17 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,841 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiquan Zhao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729333
- Sponsor's protocol ID
- XHEC-C-2024-205-1
- Acronym
- SChiROP
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China
- ClinicalTrials.gov ID
- NCT06729333
- Acronym / sponsor ID
- SChiROP / XHEC-C-2024-205-1
- Keywords
- retinopathy of prematurity, incidence rate, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,841 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 17 May 2026 (actual)
- Study completion
- 17 May 2026 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tertiary hospital
Key inclusion criteria (1 listed)
- From December 2024 to May 2025, preterm infants (gestational age <37 weeks) or low birth weight infants (birth weight <2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.
Key exclusion criteria (8 listed)
- Death before the first screening;
- Death or loss to follow-up before complete retinal vascularization;
- Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;
- Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;
- Poor systemic condition preventing fundus examination;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence rate of ROP
Time frame: 6 months after the first screening
Gestational age at which treatment-requiring ROP develops
Time frame: 6 months after the first screening
Birthweight at which treatment-requiring ROP develops
Time frame: 6 months after the first screening
5 secondary outcomes
Gestational age of infants developing any ROP lesion
Time frame: 6 months after the first screening
Birthweight of infants developing any ROP lesion
Time frame: 6 months after the first screening
Postmenstrual age (PMA) at which ROP lesions occur
Time frame: 6 months after the first screening
PMA at which treatment-requiring ROP occurs
Time frame: 6 months after the first screening
Screening and treatment costs
Time frame: 6 months after the first screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Related trials for Premature Birth of Newborn
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth of Newborn and Retinopathy of Prematurity (ROP), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of ROP (time frame: 6 months after the first screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.